FDA Certitudes: The Creation of an OTC Drug Monograph User Fee Program

By Kurt R. Karst –  

There are general life certitudes, such as the quote attributed to Benjamin Franklin: “In this world nothing can be said to be certain, except death and taxes.”  There are also FDA certitudes we’ve come to recognize.  For example, “everything eventually goes generic” . . . . and eventually FDA will be completely “UFAized.” (“UFAization” is the process by which an FDA component gets to collect fees from industry after the enactment of a User Fee Act – “UFA” – and then subsequently becomes focused on so-called process enhancements to meet goals and commitments.)  So we weren’t at all surprised when FDA announced in a Federal Register notice (Docket No. FDA-2016-N-1092) that will be published later this week (as well as in a FAQ document) that the Agency will hold a public meeting on June 10, 2016 “to gather stakeholder input on the potential development of a user fee program for nonprescription (over-the-counter or OTC) monograph drugs.” That’s right; in addition to all of the other FDA User Fee Programs already in existence, we may soon see an OTC Drug Monograph User Fee Program.

The OTC drug monograph system has been around for quite some time – since 1972 – and it “remains one of the largest and most complex regulatory programs ever undertaken at FDA,” according to FDA. But the process of completing and updating monographs has moved at a glacial pace.  FDA has previously discussed some potential reforms to streamline the process (see our previous post here), but those reforms have not yet panned out.  The creation of a user fee program, however, could result in a “stable and predictable source of adequate funding” that would allow FDA to more quickly complete OTC drug reviews. 

Crafting a user fee program for OTC monograph drugs will certainly require some tailoring to the unique aspects of the monograph system. As FDA recognizes in the Agency’s meeting announcement notice: 

There are some important differences between marketing through approved applications and marketing under the monographs. NDAs and ANDAs are product-based; an application typically is submitted with data for a single drug product to be marketed by a single sponsor, and that application will be approved or not approved.  By contrast, the monograph system is ingredient-based; numerous sponsors may make the same ingredient for the same use, and all may market drug products made with this ingredient as long as they comply with all applicable regulations, including the conditions of the monograph.  Sponsors of monograph drugs are not required to seek FDA approval prior to marketing a product under the monograph.  In addition, the monograph system, where ingredients are determined to be GRASE or not, is a public process. Data are submitted to public dockets, and anyone may provide input.  By contrast, while FDA typically makes NDA information public after approval of a product, it generally cannot do so before. 

With that in mind, FDA lays out the case for the creation of an OTC Drug Monograph User Fee Program, saying that there are several potential benefits:

• Ability to address safety issues of currently marketed products in an efficient and timely manner.
• Timely determination on the safety and efficacy of monograph ingredients under the conditions of the monograph, helping to assure appropriate marketing of thousands of nonprescription products used daily by U.S. consumers.
• Increased availability of certain monograph product innovations proposed by industry.
• Streamlined ability to update monographs to allow modern testing methods in several areas, potentially reducing the need for animal testing, and simplifying and speeding product development.
• Development of information technology infrastructure to speed numerous parts of the monograph review process, and enable a modern robust system for submission of materials and archiving of documents.
• Development of a modern, useful, and transparent FDA monograph website to provide the public and industry with access to important information.
• Ability to hold more public meetings on important monograph issues.
• Increased ability of FDA to respond to monograph-related concerns and questions from the public and industry.
• Establishment of additional infrastructure for the efficient continued conduct of monograph activities in the longer term.

Before the pubic meeting takes place on June 10th, FDA wants folks to chew on a few questions: (1) What types of user fees (e.g., product listing fees, facility fees, application fees, other types of fees) might be appropriate for a potential monograph user-fee program?; (2) What types of performance goals might be important to consider from a public health and sponsor perspective?; and (3) What parameters could be measured to gauge the success of a user-fee program? Many more questions will likely surface in the coming weeks and months as the skeleton of a system is fleshed out. Whether a system that the OTC drug industry can agree to can be hammered out in time for the next round of UFA reauthorizations in 2017 remains to be seen. . . . But it will happen . . . eventually.